MAUDE Adverse Event Report: EMBECTA MEDICAL I LLC BD SAFETYGLIDE; PISTON SYRINGE

Catalog Number	303327
Medical Device Problem Code	Contamination (1120)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/21/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
H.3.If a device evaluation and/or device history review is completed, a supplemental report will be filed.
Event or Problem Description
It was reported that the bd syringe safetyglide 1ml w/ndl 27x3/8 ib had foreign matter.The following information was provided by the initial reporter: material # 303327 batch # unknown verbatim: rcc received a complaint via phone.Pir attached.Piece of plastic type material in syringe.Discovered when drawing up medication.No harm, did not leave pharmacy, identified by pharmacy technician product description bd safetyglide 1ml syringe 27g 3/8' grey cap ref#303327.
Event or Problem Description
Samples.
Additional Manufacturer Narrative
One opened syringe and two unopened mat# 303327 were received and tested by our quality team with the customer's complaint of foreign matter.The complaint was immediately verified upon initial visual inspection due to a transparent blob in the opened syringe's barrel.An attempt was made to draw water into the syringe but the material inside syringe was temporarily clogging the syringe.The barrel was cut open and the substance was extracted.The foreign matter was quickly realized to be solvent (or glue) that had been improperly applied in excess during production.This is the root cause of this failure- operator error during the assembly of needle to barrel and subsequent quality control oversight in allowing the syringe to reach consumer.The 2 unopened syringes had no issues and performed as intended.No corrective actions are necessary at this time due to the manufacture plant having shut down since the production of this syringe.The production history was analyzed and there were no issues found during quality inspections that would lead to this issue.

• Brand Name: BD SAFETYGLIDE
• Common Device Name: PISTON SYRINGE
• Manufacturer (Section D): EMBECTA MEDICAL I LLC; 1329 west highway 6; holdrege NE 68949
• Manufacturer (Section G): EMBECTA MEDICAL I LLC; 1329 west highway 6; holdrege NE 68949
• Manufacturer Contact: helen cox (mdr) ; 75 north fairway drive; vernon hills, IL 60061 ; 8473935694
• MDR Report Key: 23526202
• Report Number: 2243072-2025-01386
• Device Sequence Number: 10026967
• Product Code: FMF
• UDI-Device Identifier: 00382903033270
• UDI-Public: (01)00382903033270
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K951254
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,User Facility
• Initial Reporter Occupation: Pharmacist
• Type of Report: Initial,Followup
• Report Date (Section B): 01/22/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: 303327
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/10/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/22/2025
• Supplement Date Received by Manufacturer: 01/22/2026
• Initial Report FDA Received Date: 11/11/2025
• Supplement Report FDA Received Date: 01/22/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown